Congenital Heart DiseaseNCT04151160
Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease
An observational study of Congenital Heart Disease and Edema, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Read more about this study
- Who is it for?
- Ages 0 days to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Edema, Fluid Overload
- What is being tested?
- Point of care ultrasound measurements
- Type of treatment
- Pill or oral medicine
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Case subjects: Infants with hemodynamically significant congenital heart disease. Control subjects: Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.
Who may be able to join
- Age less than or equal to 12 months old at the time of enrollment
- Known hemodynamically significant congenital heart disease
- Undergoing surgery, with or without cardiopulmonary bypass, to repair or palliate their congenital heart defect
- Age less than or equal to 12 months old at the time of enrollment
- No known heart disease OR presence of only non-hemodynamically significant congenital heart disease, including: tiny muscular ventricular septal defect, patent foramen ovale, peripheral pulmonary stenosis, normally functioning bicuspid aortic valve (no stenosis and no more than trivial insufficiency), and tiny patent ductus arteriosus
Who cannot join
- Known renal dysfunction
- Prematurity less than 36 weeks corrected gestational age
- Control Subjects:
- History of hemodynamically significant congenital heart disease
- History of surgery with general anesthesia
- Known renal dysfunction
- Prematurity less than 36 weeks corrected gestational age
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Using Point of Care Ultrasound to Measure Perioperative Edema in Infants With Congenital Heart Disease
Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.
Read the detailed description
Congenital heart disease is the most common birth defect and occurs in ~8 per 1000 live births in the United States. Approximately 25% of these infants require surgery in the first year of life to repair or palliate their heart defect. Many cardiac surgeries require the use of cardiopulmonary bypass to maintain systemic blood flow and oxygen delivery during surgery. Cardiopulmonary bypass is not a natural process, and, as a result, contributes to post-operative physiologic derangements including ischemia-reperfusion injury, systemic inflammatory response, and subsequent fluid overload.
Fluid overload, in particular, is a common issue in children undergoing cardiac surgery, particularly in the immediate post-operative period. The rates of fluid overload following cardiothoracic surgery are high, reported between 31% and 100% in different studies depending on the method of assessment and the degree of fluid overload analyzed. Diaz et al demonstrated approximately 55% of children requiring mechanical ventilation or inotropic support in the intensive care unit developed fluid overload. Fluid overload is defined as a positive fluid balance and can occur extra or intravascularly. The buildup of excess extravascular fluid is also known as edema. The etiology of fluid overload and edema is multifactorial and includes fluid retention due neurohormonal pathway activation such as vasopressin and renin-angiotensin system, congestive heart failure, iatrogenic fluid administration, and capillary leak. Intravascular fluid overload can cause elevated central venous pressure, potentially leading to poor renal perfusion and subsequent acute kidney injury (AKI) while extravascular edema compromises abdominal and thoracic compliance and can make ventilation difficult. In the post-operative period, fluid overload has been associated with significant morbidity including AKI, longer mechanical ventilation dependence, prolonged length of stay, and increased mortality.
Unfortunately, management and treatment of fluid overload and edema are not standardized as it is currently difficult to accurately quantify the degree of fluid overload. Methods for monitoring fluid status include trending body weights, monitoring net fluid balance (intake versus output), trending central venous pressure, and physical exam findings. All of these current methods for monitoring fluid status can easily be confounded in the intensive care unit. A paucity of data exists regarding accurate methods of assessing edema in infants. Objective methods of evaluating fluid overload have been attempted, but are limited to measuring only intravascular volume, such as ultrasound of the jugular vein, or are difficult to apply clinically, such as skin bioelectric impedance. Additional research is needed to better understand and directly measure edema in infants.
Ultrasound of the skin is one possible method for quantifying extravascular fluid overload and edema through measurement of the thickness of skin and underlying subcutaneous layers. Ultrasound has previously been utilized in pediatric patients to diagnose skin and soft tissue infections, but there are no dedicated studies performed to solely measure edema. MuscleSound, an ultrasound technology company, has developed an automated software system to measure skin tissue structures, including edema, in adults. This technology has been studied in adults, however, it has not yet been trialed or validated in children. The ability to evaluate edema with a reliable, automated, non-invasive, bedside tool would provide objective measurements into a patient's fluid status. This tool would be of particular importance in infants with congenital heart disease who have many risk factors for fluid overload but whose fluid status can be difficult to appropriately assess.
- Conditions
- Congenital Heart Disease, Edema, Fluid Overload
- Being tested
- Point of care ultrasound measurements
- Keywords
- MuscleSound
- Medical subject headings
- Heart Defects, Congenital, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasound measurementsDiagnostic test
- Ultrasound images will be obtained using a commercial, high frequency, linear Philips ultrasound probe attached to small, portable tablet. This tablet will have the capability of transferring the saved images to the secure MuscleSound cloud-based server.
| Study group | Role | What they receive |
|---|---|---|
| Case Subjects | Infants with hemodynamically significant congenital heart disease. Receives: Diagnostic Test: Point of care ultrasound measurements | |
| Control Subjects | Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease. Receives: Diagnostic Test: Point of care ultrasound measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Measurement of Edema
Depth (in millimeters) of edema from skin ultrasound measurements.
Measured: Up to Post-Op Day 5
Secondary outcomes (11)
Change in Daily Weight
Weight will be recorded in kilograms (kg)
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5
Daily Fluid Balance (intake and output)
Hourly fluid intake and output will be measured in milliliters (mL)
Measured: Up to Post-Op Day 5
CVP Measurements
Current central venous pressure (CVP) will be documented in millimeters of Mercury (mmHg) at the time of the each daily ultrasound
Measured: Up to Post-Op Day 5
Documentation of edema
Presence of edema documented in the Electronic Medical Record (EMR)
Measured: Up to Post-Op Day 5
Reports of pulmonary edema and/or pleural effusions on chest x-ray reports
Documentation of "pulmonary edema" and/or "pleural effusions". If pulmonary edema and/or pleural effusions are documented on chest x-ray, then this will be added to the study data collection form, including the documented severity (ranging from "minimal", "mild", "moderate", and "large")
Measured: Up to Post-Op Day 5
Daily diuretic dose
Total amount of diuretics given in the post-operative period (and day prior to surgery).The diuretic dose over each 24 hour post-operative period (from post-operative day 0 up to post-operative day 5) will be divided by the subject's weight in kilograms leading to a total daily diuretic dose in "mcg/kg/day" or "mg/kg/day".
Measured: Up to Post-Op Day 5
Daily positive pressure ventilation (invasive or non-invasive),
Documentation of mechanical ventilation, Continuous positive airway pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP), Average volume-assured pressure support (AVAPS), and SiPAP. The number of days (rounding to the nearest half day) that a patient requires any of these forms of positive pressure ventilation will be documented.
Measured: Up to Post-Op Day 5
Length of mechanical ventilation (hours),
Documentation of mechanical ventilation, CPAP, BiPAP, AVAPS, and SiPAP. The hours that a patient requires mechanical ventilation in the post-operative period will be calculated and documented
Measured: Up to Post-Op Day 5
Intensive care unit length of stay (days)
The days spent in the intensive care unit in the post-operative period will be calculated and documented
Measured: Up to Post-Op Day 5
Development of Acute Kidney Injury (AKI) using the Acute Kidney Injury Network (AKIN) scoring system
The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI.
Measured: Up to Post-Op Day 5
Post-operative mortality
Death during their hospitalization after surgery or within 30 days in the post-operative period
Measured: Up to 30 days Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start13 Jan 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- MuscleSound
- Responsible party
- Sponsor
- Investigators
- Jessica Persson, MD, Principal investigator, University of Colorado, DenverJesse Davidson, MD, Study director, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151160
- Sponsor's protocol ID
- 19-1387
- Status last verified
- May 2023
- First submitted
- 15 Oct 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Shuler CO, Black GB, Jerrell JM. Population-based treated prevalence of congenital heart disease in a pediatric cohort. Pediatr Cardiol. 2013 Mar;34(3):606-11. doi: 10.1007/s00246-012-0505-3. Epub 2012 Sep 14.
PubMed 22976198Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
PubMed 12084585Raja SG, Dreyfus GD. Modulation of systemic inflammatory response after cardiac surgery. Asian Cardiovasc Thorac Ann. 2005 Dec;13(4):382-95. doi: 10.1177/021849230501300422.
PubMed 16304234Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.
PubMed 8431082Seguin J, Albright B, Vertullo L, Lai P, Dancea A, Bernier PL, Tchervenkov CI, Calaritis C, Drullinsky D, Gottesman R, Zappitelli M. Extent, risk factors, and outcome of fluid overload after pediatric heart surgery*. Crit Care Med. 2014 Dec;42(12):2591-9. doi: 10.1097/CCM.0000000000000517.
PubMed 25072753Hassinger AB, Wald EL, Goodman DM. Early postoperative fluid overload precedes acute kidney injury and is associated with higher morbidity in pediatric cardiac surgery patients. Pediatr Crit Care Med. 2014 Feb;15(2):131-8. doi: 10.1097/PCC.0000000000000043.
PubMed 24366508Diaz F, Benfield M, Brown L, Hayes L. Fluid overload and outcomes in critically ill children: A single center prospective cohort study. J Crit Care. 2017 Jun;39:209-213. doi: 10.1016/j.jcrc.2017.02.023. Epub 2017 Feb 16.
PubMed 28254390Wilder NS, Yu S, Donohue JE, Goldberg CS, Blatt NB. Fluid Overload Is Associated With Late Poor Outcomes in Neonates Following Cardiac Surgery. Pediatr Crit Care Med. 2016 May;17(5):420-7. doi: 10.1097/PCC.0000000000000715.
PubMed 27028790Sampaio TZ, O'Hearn K, Reddy D, Menon K. The Influence of Fluid Overload on the Length of Mechanical Ventilation in Pediatric Congenital Heart Surgery. Pediatr Cardiol. 2015 Dec;36(8):1692-9. doi: 10.1007/s00246-015-1219-0. Epub 2015 Jun 30.
PubMed 26123810Lex DJ, Toth R, Czobor NR, Alexander SI, Breuer T, Sapi E, Szatmari A, Szekely E, Gal J, Szekely A. Fluid Overload Is Associated With Higher Mortality and Morbidity in Pediatric Patients Undergoing Cardiac Surgery. Pediatr Crit Care Med. 2016 Apr;17(4):307-14. doi: 10.1097/PCC.0000000000000659.
PubMed 26914622Delpachitra MR, Namachivayam SP, Millar J, Delzoppo C, Butt WW. A Case-Control Analysis of Postoperative Fluid Balance and Mortality After Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2017 Jul;18(7):614-622. doi: 10.1097/PCC.0000000000001170.
PubMed 28492405Lombel RM, Kommareddi M, Mottes T, Selewski DT, Han YY, Gipson DS, Collins KL, Heung M. Implications of different fluid overload definitions in pediatric stem cell transplant patients requiring continuous renal replacement therapy. Intensive Care Med. 2012 Apr;38(4):663-9. doi: 10.1007/s00134-012-2503-6. Epub 2012 Feb 11.
PubMed 22327560van Asperen Y, Brand PL, Bekhof J. Reliability of the fluid balance in neonates. Acta Paediatr. 2012 May;101(5):479-83. doi: 10.1111/j.1651-2227.2012.02591.x. Epub 2012 Jan 27.
PubMed 22220764Bontant T, Matrot B, Abdoul H, Aizenfisz S, Naudin J, Jones P, Dauger S. Assessing fluid balance in critically ill pediatric patients. Eur J Pediatr. 2015 Jan;174(1):133-7. doi: 10.1007/s00431-014-2372-9. Epub 2014 Jul 4.
PubMed 24990494
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Point of Care Ultrasound to Measure Perioperative Edema in Infants With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04151160
- Acronym / sponsor ID
- 19-1387
- Conditions
- Congenital Heart Disease, Edema, Fluid Overload
- Keywords
- MuscleSound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- MuscleSound
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.
Detailed description
Congenital heart disease is the most common birth defect and occurs in ~8 per 1000 live births in the United States. Approximately 25% of these infants require surgery in the first year of life to repair or palliate their heart defect. Many cardiac surgeries require the use of cardiopulmonary bypass to maintain systemic blood flow and oxygen delivery during surgery. Cardiopulmonary bypass is not a natural process, and, as a result, contributes to post-operative physiologic derangements including ischemia-reperfusion injury, systemic inflammatory response, and subsequent fluid overload.
Fluid overload, in particular, is a common issue in children undergoing cardiac surgery, particularly in the immediate post-operative period. The rates of fluid overload following cardiothoracic surgery are high, reported between 31% and 100% in different studies depending on the method of assessment and the degree of fluid overload analyzed. Diaz et al demonstrated approximately 55% of children requiring mechanical ventilation or inotropic support in the intensive care unit developed fluid overload. Fluid overload is defined as a positive fluid balance and can occur extra or intravascularly. The buildup of excess extravascular fluid is also known as edema. The etiology of fluid overload and edema is multifactorial and includes fluid retention due neurohormonal pathway activation such as vasopressin and renin-angiotensin system, congestive heart failure, iatrogenic fluid administration, and capillary leak. Intravascular fluid overload can cause elevated central venous pressure, potentially leading to poor renal perfusion and subsequent acute kidney injury (AKI) while extravascular edema compromises abdominal and thoracic compliance and can make ventilation difficult. In the post-operative period, fluid overload has been associated with significant morbidity including AKI, longer mechanical ventilation dependence, prolonged length of stay, and increased mortality.
Unfortunately, management and treatment of fluid overload and edema are not standardized as it is currently difficult to accurately quantify the degree of fluid overload. Methods for monitoring fluid status include trending body weights, monitoring net fluid balance (intake versus output), trending central venous pressure, and physical exam findings. All of these current methods for monitoring fluid status can easily be confounded in the intensive care unit. A paucity of data exists regarding accurate methods of assessing edema in infants. Objective methods of evaluating fluid overload have been attempted, but are limited to measuring only intravascular volume, such as ultrasound of the jugular vein, or are difficult to apply clinically, such as skin bioelectric impedance. Additional research is needed to better understand and directly measure edema in infants.
Ultrasound of the skin is one possible method for quantifying extravascular fluid overload and edema through measurement of the thickness of skin and underlying subcutaneous layers. Ultrasound has previously been utilized in pediatric patients to diagnose skin and soft tissue infections, but there are no dedicated studies performed to solely measure edema. MuscleSound, an ultrasound technology company, has developed an automated software system to measure skin tissue structures, including edema, in adults. This technology has been studied in adults, however, it has not yet been trialed or validated in children. The ability to evaluate edema with a reliable, automated, non-invasive, bedside tool would provide objective measurements into a patient's fluid status. This tool would be of particular importance in infants with congenital heart disease who have many risk factors for fluid overload but whose fluid status can be difficult to appropriately assess.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Subjects | – | Diagnostic Test: Point of care ultrasound measurementsInfants with hemodynamically significant congenital heart disease. |
| Control Subjects | – | Diagnostic Test: Point of care ultrasound measurementsHealthy infants with no heart disease or non-hemodynamically significant congenital heart disease. |
Who may qualify
- Ages
- 0 days to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Case subjects: Infants with hemodynamically significant congenital heart disease. Control subjects: Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.
Key inclusion criteria (5 listed)
- Age less than or equal to 12 months old at the time of enrollment
- Known hemodynamically significant congenital heart disease
- Undergoing surgery, with or without cardiopulmonary bypass, to repair or palliate their congenital heart defect
- Age less than or equal to 12 months old at the time of enrollment
- No known heart disease OR presence of only non-hemodynamically significant congenital heart disease, including: tiny muscular ventricular septal defect, patent foramen ovale, peripheral pulmonary stenosis, normally functioning bicuspid aortic valve (no stenosis and no more than trivial insufficiency), and tiny patent ductus arteriosus
Key exclusion criteria (7 listed)
- Known renal dysfunction
- Prematurity less than 36 weeks corrected gestational age
- History of hemodynamically significant congenital heart disease
- History of surgery with general anesthesia
- Known renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care ultrasound measurementsi. Ultrasound images will be obtained using a commercial, high frequency, linear Philips ultrasound probe attached to small, portable tablet. This tablet will have the capability of transferring the saved images to the secure MuscleSound cloud-based server. | Diagnostic test | Case Subjects, Control Subjects |
Primary outcome
Ultrasound Measurement of Edema
Time frame: Up to Post-Op Day 5
Depth (in millimeters) of edema from skin ultrasound measurements.
11 secondary outcomes
Change in Daily Weight
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5
Daily Fluid Balance (intake and output)
Time frame: Up to Post-Op Day 5
CVP Measurements
Time frame: Up to Post-Op Day 5
Documentation of edema
Time frame: Up to Post-Op Day 5
Reports of pulmonary edema and/or pleural effusions on chest x-ray reports
Time frame: Up to Post-Op Day 5
Daily diuretic dose
Time frame: Up to Post-Op Day 5
Daily positive pressure ventilation (invasive or non-invasive),
Time frame: Up to Post-Op Day 5
Length of mechanical ventilation (hours),
Time frame: Up to Post-Op Day 5
Intensive care unit length of stay (days)
Time frame: Up to Post-Op Day 5
Development of Acute Kidney Injury (AKI) using the Acute Kidney Injury Network (AKIN) scoring system
Time frame: Up to Post-Op Day 5
Post-operative mortality
Time frame: Up to 30 days Post-Op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 22976198Shuler CO, Black GB, Jerrell JM. Population-based treated prevalence of congenital heart disease in a pediatric cohort. Pediatr Cardiol. 2013 Mar;34(3):606-11. doi: 10.1007/s00246-012-0505-3. Epub 2012 Sep 14.
- Background: PubMed 12084585Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
- Background: PubMed 16304234Raja SG, Dreyfus GD. Modulation of systemic inflammatory response after cardiac surgery. Asian Cardiovasc Thorac Ann. 2005 Dec;13(4):382-95. doi: 10.1177/021849230501300422.
- Background: PubMed 8431082Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.
- Background: PubMed 25072753Seguin J, Albright B, Vertullo L, Lai P, Dancea A, Bernier PL, Tchervenkov CI, Calaritis C, Drullinsky D, Gottesman R, Zappitelli M. Extent, risk factors, and outcome of fluid overload after pediatric heart surgery*. Crit Care Med. 2014 Dec;42(12):2591-9. doi: 10.1097/CCM.0000000000000517.
- Background: PubMed 24366508Hassinger AB, Wald EL, Goodman DM. Early postoperative fluid overload precedes acute kidney injury and is associated with higher morbidity in pediatric cardiac surgery patients. Pediatr Crit Care Med. 2014 Feb;15(2):131-8. doi: 10.1097/PCC.0000000000000043.
- Background: PubMed 28254390Diaz F, Benfield M, Brown L, Hayes L. Fluid overload and outcomes in critically ill children: A single center prospective cohort study. J Crit Care. 2017 Jun;39:209-213. doi: 10.1016/j.jcrc.2017.02.023. Epub 2017 Feb 16.
- Background: PubMed 27028790Wilder NS, Yu S, Donohue JE, Goldberg CS, Blatt NB. Fluid Overload Is Associated With Late Poor Outcomes in Neonates Following Cardiac Surgery. Pediatr Crit Care Med. 2016 May;17(5):420-7. doi: 10.1097/PCC.0000000000000715.
- Background: PubMed 26123810Sampaio TZ, O'Hearn K, Reddy D, Menon K. The Influence of Fluid Overload on the Length of Mechanical Ventilation in Pediatric Congenital Heart Surgery. Pediatr Cardiol. 2015 Dec;36(8):1692-9. doi: 10.1007/s00246-015-1219-0. Epub 2015 Jun 30.
- Background: PubMed 26914622Lex DJ, Toth R, Czobor NR, Alexander SI, Breuer T, Sapi E, Szatmari A, Szekely E, Gal J, Szekely A. Fluid Overload Is Associated With Higher Mortality and Morbidity in Pediatric Patients Undergoing Cardiac Surgery. Pediatr Crit Care Med. 2016 Apr;17(4):307-14. doi: 10.1097/PCC.0000000000000659.
- Background: PubMed 28492405Delpachitra MR, Namachivayam SP, Millar J, Delzoppo C, Butt WW. A Case-Control Analysis of Postoperative Fluid Balance and Mortality After Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2017 Jul;18(7):614-622. doi: 10.1097/PCC.0000000000001170.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Persson, MD principal investigator
University of Colorado, Denver
Jesse Davidson, MD study director
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Edema, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Measurement of Edema (time frame: Up to Post-Op Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151160, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.